Roche (OTCQX:RHHBY) unit, Genentech will present new Enspryng (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. These data are being presented at MSVirtual2020.
In a post-hoc analysis of the Enspryng-treated group, the risk of severe relapse was reduced by 79% compared to placebo (5 of 27 [19%] vs. 12 of 34 [35%]), for patients across the double-blind periods of the SAkura studies.
Preventing relapses is the primary goal for NMOSD treatment management. The patients treated with Enspryng were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, p=0.015). A relapse was categorized as severe if it resulted in a change of ≥2 points on the Expanded Disability Status Scale.
In a separate pooled analysis, Enspryng reduced the risk of relapse in the combined double-blind period and open-label extension (OLE) by 51% (HR, 0.49; 95% CI, 0.31–0.79; p=0.002) compared to those originally in the placebo group. This effect was more pronounced in aquaporin-4 antibody (AQP4-IgG) seropositive patients, with 66% reduction in risk of relapse compared to the placebo group.
In the double-blind periods, infection rates were lower in the Enspryng-treated group compared to placebo in the SAkuraStar study (99.8 vs. 162.6 events/100 patient years [PY]), whereas infection rates did not differ between groups in the SAkuraSky study.
Satralizumab is an interleukin-6 (IL-6) receptor inhibitor. IL-6 is believed to pay a key role in NMOSD inflammation.
Previously: Roche’s satralizumab successful in second late-stage NMOSD study (Sept. 12, 2019)